1. Field of the Invention
The present invention relates to a device for sterilization check and, in particular, to a device for sterilization check capable of checking a sterilization effect on an internal pipeline of an endoscope.
2. Description of the Related Art
Medical endoscopes perform an observation of organs and the like by having an insertion unit inserted into a body cavity, or various remedies and treatments by using a treatment instrument inserted into a treatment instrument insertion path (which is also referred to as a “treatment tool insertion channel or a “forceps channel”) of the endoscope. Therefore, when an endoscope having once been used is to be reused for another patient, the endoscope is required to be disinfected and sterilized after the end of examination and treatment to prevent infection between patients via the endoscope. Disinfection or sterilization is achieved by methods of using a disinfectant liquid, ethylene oxide gas, formalin gas, hydrogen peroxide gas plasma, ozone, a sterilized autoclave which uses water vapor high temperature and high pressure, and others.
A hydrogen peroxide plasma method is a typical advanced sterilizing methodology for endoscopes. In this method, hydrogen peroxide is decomposed with plasma to generate active hydroxy radicals, thereby achieving sterilization. Also, using an autoclave that sterilizes an endoscope with steam at high temperature and high pressure is a disinfecting and sterilizing methodology that has been widespread. Either methodology has many advantages, such as a highly reliable sterilization effect, free of residual toxicity, and low running cost.
In this sterilizing process, an operation of checking whether the sterilization effect by that sterilizing process has been sufficiently obtained is normally performed. In this checking operation, a sterilization indicator indicating that a subject to be sterilized has been subjected to the sterilizing process is used. The sterilization indicator indicates that the subject to be sterilized has been exposed to a sterilizing medium (heat or gas) for a predetermined period of time, and is a member having a non-reversible discoloration characteristic. In general, the sterilization indicator having this discoloration characteristic is a card-shaped, label-shaped, or tape-shaped material, and may be directly affixed to a medical instrument such as an endoscope or may be enclosed in a hermetically-sealed package. A doctor or a nurse checks the color of the sterilization indicator when opening the hermetically-sealed package and, if the color is changed to a predetermined color, believes that the sterilizing process is complete and uses the instrument for examinations, operations, and others.
In the case of a medical instrument configured not to have an elongated pipeline in the subject to be sterilized, a general sterilization indicator is affixed to the surface of the subject to be sterilized, thereby allowing the sterilization effect to be checked.
However, the inner pipeline of the endoscope has an elongated pipeline structure, which is difficult to check whether the sterilizing medium has reliably reached the inside of the inner pipeline. Therefore, even if the surface of the endoscope is exposed to the sterilizing medium, it is not known whether this sterilizing medium has passed through the inner pipeline, and the operation of checking whether the sterilizing process has been appropriately performed is not sufficient.
Japanese Patent Application Laid-Open No. 2002-355297 suggests an indicator for sterilization check, in which a linear subject having attached thereto a sterilization indicator composite is inserted in a narrow pipeline to allow sterilization in the pipeline to be checked.
Japanese Patent Application Laid-Open No. 2005-204826 suggests, as a device for sterilization check suitable for checking a sterilization effect on an elongated inner pipeline as an endoscope, a device including a pipeline tube having a variable pipeline diameter and an indicator case connected to the pipeline tube and capable of accommodating an indicator for sterilization check in a space communicating with an inner space of the pipeline tube.